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Year in Review

Orthobiologics Update: Soft Tissue Repair/Replacement Technologies

The use of orthobiologics for soft tissue applications for cartilage repair and regeneration was one of the first successful applications of soft tissue engineering in orthopaedics, and it remains a larger focus in orthobiologics today. What follows are recent strategic activities for orthobiologic companies offering technologies for soft tissue repair and replacement, as well as an update on products, their application and availability.
In late 2Q14, Aastrom Biosciences, a manufacturer of autologous cell therapy products for cartilage repair, acquired Sanofi’s Cell Therapy and Regenerative Medicine business for $6.5 million, gaining access to Carticel® autologous cultured chondrocytes and MACI® matrix-applied characterized autologous cultured chondrocytes. Soon thereafter, Aastrom announced plans to temporarily cease European sales of MACI, clarify its FDA registration path and drive profitability of Carticel. News of a name change and HQ relocation followed in October. At a time not yet specified, the company will be known as Vericel, based in Cambridge, Massachusetts. 
In mid-2Q, Active Implants received IDE approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant in knee osteoarthritis patients. The prospective, randomized, multicenter VENUS (Verification of the Effectiveness of the NUsurface System) study is comparing NUsurface to the current standard of care for treating persistent knee pain following meniscectomy.
Within 4Q14, Histogenics and Intrexon formed an Exclusive Channel Collaboration to generate allogeneic chondrocyte cell therapeutics to repair damaged articular hyaline cartilage. The partnership will combine Histogenics’ solutions for musculoskeletal-related conditions and Intrexon’s technologies to develop an allogeneic cell treatment for cartilage repair.
In 2013, ISTO Technologies and Zimmer terminated an agreement to co-develop DeNovo® ET Engineered Tissue used in the treatment of knee cartilage defects. ISTO has renamed the ET product as RevaFlex™ and is proceeding independently through development of a Phase III clinical program in its support. ISTO has transferred ownership of DeNovo NT particulated juvenile cartilage allograft to Zimmer.
Finally, in 4Q14, Osiris Therapeutics entered into an exclusive commercialization and development partnership with Arthrex for Cartiform®, Osiris’ viable chondral allograft product for cartilage repair in the knee, foot, ankle, etc. 
The exhibit below details various players in the orthobiologic soft tissue repair and replacement segment, as well as their products on the market or in development. This table is an update to Exhibit 72, Soft Tissue Repair/Replacement Product Landscape from the Orthobiologics chapter of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®, 2014 installment.

Company Product(s) Application(s) Availability
Aastrom Biosciences Carticel autologous cultured chondrocytes Knee cartilage repair EU, US
Aastrom Biosciences MACI Matrix-induced Autologous Chondrocyte Implantation Knee cartilage repair Australia, EU, phase III product candidate in US
Active Implants NuSurface implant Treatment of meniscal-deficient knee Postmarket study in EU/Israel; IDE trial approved for EU/US
Aesculap Novocart 3D autologous chondrocytes on a biphasic matrix Knee cartilage repair EU; 1st human implantation of 3D in FDA IND Phase III randomized, partially-blinded multi-center study
Aesculap Novocart Disc autologous cell compound in hydrogel Disc cartilage repair EU, with U.S. clinical trial ongoing
Aesculap Novocart Inject, autologous cartilage cells + in situ polymerizable hydrogel Articular cartilage defect repair Ongoing U.S. observational study in hip
Anika Therapeutics Hyaloss HYAFF fibers Used to mix blood/bone grafts to form a paste for bone regeneration EU, Asia
Arthro Kinetics CaReS collagen type I matrix colonized with autologous cartilage cells Knee cartilage repair Hong Kong, Taiwan
Arthro Kinetics CaReS 1-S (One-step) Cell Free Implant system Full-layer, localized small cartilage defects up to 8 cm EU
Audax Arxis "twin-base linker" molecules, made of carbon, nitrogen and oxygen, resembling nanoscale tubes that are packed with antibiotics, anti-inflammatory agents and bone growth factors Diseased and damaged tissue due to osteoporosis, osteoarthritis, trauma Pre-clinical animal study
BioTissue Technologies BioSeed-C autologous 3D chondrocyte graft Knee cartilage repair EU
CartiHeal Agili-C cell-free implant Cartilage and osteochondral defects EU; ex-U.S. clinical evaluation ongoing
Cartiva Cartiva polyvinyl alcohol cryogel Cartilage repair (OA of knee, first MTP joint and CMC) Brazil, Canada, EU; clinical trial in Canada and U.K. ongoing
CellCoTec INSTRUCT cell-based theraphy + autologous bone marrow + polymer scaffold Knee cartilage repair Pilot clinicals, EU
co.don chondrotransplant DISC autologous disc cell transplantation Disc repair EU
co.don chondrosphere (ACI with damaged cartilage cells) Arthroscopic hip, knee and ankle cartilage repair Phase II clinical trial ongoing (knee)
CollPlant VerGenix STI recombinant human collagen matrix, combines with autologous PRP to form a scaffold in tendon injury site Tendon repair augmentation In development; targeting CE Mark in 2015
Cytex Therapeutics Bio-artificial cartilage (3D scaffold woven seeded with biocompatible gel, adipose-derived adult stem cells + growth factors) Knee, shoulder and other joint cartilage repair In development
DePuy Synthes Cartilage Autograft Implantation System Repair of articular cartilage lesions Clinical trials ongoing in U.S. and Singapore
EduCell ChondroArt 3D alginate-agarose hydrogel scaffold for chondrocytes Articular cartilgae repair EU
Exactech Cartilage repair implant Knee cartilage repair IDE in Taiwan
Fibralign Nanoweave collagen-based matrices Tendon repair Asia Pacific, Canada, EU, Middle East, US
Geistlich Surgery Chondro-Gide bilayer collagen membrane Articular cartilage repair in knee, talus, hip and shoulder EU
Graftys Adult stem cells + 3D matrices Cartilage and bone grafts In development
Histogenics NeoCart autologous cells in a collagen scaffold Knee cartilage repair Phase III US clinical study ongoing
ISTO Technologies RevaFlex scaffold-free living cartilage implant Knee cartilage repair Phase III US clinical study ongoing
Ivy Sports Medicine Collagen Meniscus Implant (formerly Menaflex) Meniscus repair Germany
Japan Tissue Engineering JACC Autologous Cultured Cartilage Knee repair Japan
Orteq Bioengineering Actifit biodegradable polyurethane scaffold Meniscal tears EU
Orthocell Autologous Tenocyte Implantation Chronic resistant tendon injury Australia
Orthocell Celgro collagen scaffold Tissue augmentation or replacement in rotator cuff, Achilles, patella and quadriceps tendons Australia
Orthox FibroFix silk protein technology Meniscal and articular cartilage repair In development
Osiris CartiForm viable chondral allograft (viable chondrocytes, chondrogenic growth factors + extracellular matrix proteins within the intact architecture of healthy hyaline cartilage) Cartilage repair in knee, foot, ankle, other major joints US
Piramal BST-CarGel (in situ ionic polysaccharide gel) Treatment of focal cartilage lesions EU; Phase III clinical study internationally
Regenerative Medical CARTIFILL collagen-based cartilage cell scaffold For use with microfracture Asia Pacific, EU, India
Regentis Biomaterials Gelrin C (cartilage) matrix for autologous chondrogenic extract + hydrogel; becomes semi-solid with UV light exposure Knee cartilage repair EU; patient enrollment complete for multi-center clinical study
Rotation Medical Collagen scaffold technology Rotator cuff/tendon injuries FDA cleared; US postmarket clinical study underway
Schwartz Biomedical Soft tissue/tissue engineering scaffold fixation technologies Repair of articular cartilage, meniscus and rotator cuff In development
Schwartz Biomedical Hyaluronic acid-based tissue engineering scaffold technologies Cartilage and meniscus repair In development
SurgaColl ChondroColl biomimetic, bioactive layered scaffold Cartilage repair Preclinical trials
TiGenix ChondroCelect Knee cartilage repair EU, Middle East, filed BLA in US
TiGenix Chondromimetic implant Repair of cartilage and bone EU
TissueGene TG-C allogeneic cell therapy Knee osteoarthritis Patient enrollment complete for Phase II US study
Zimmer DeNovo NT particulated juvenile cartilage implant Knee, hip, ankle and shoulder cartilage restoration US/Canada postmarket clinical studies ongoing in knee and ankle

As can be seen, orthobiologics have an expansive reach across orthopaedic segments. Estimated global sales of orthobiologic products exceeded $4.7 billion in 2013, and are expected to increase 2.5 percent each year through 2018. (Source: ORTHOWORLD® estimates)
This and more information on all strategic activity and technologies in the orthobiologics market can be found using the search tool on the ORTHOWORLD home page
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